Digital therapy to improve shoulder function after rotator cuff repair
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair: A Prospective, Randomized, Parallel-Group, Evaluator-Blinded Study
NA · Samsung Medical Center · NCT07255534
This project will test whether a smartphone-based digital therapeutic program helps adults regain shoulder strength and reduce pain after rotator cuff repair surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center (other) |
| Locations | 1 site (Seoul, Republic of Korea) |
| Trial ID | NCT07255534 on ClinicalTrials.gov |
What this trial studies
Adults who have undergone rotator cuff repair will be assigned to receive a smartphone-based digital therapeutic program that guides staged postoperative rehabilitation exercises or to usual care. The digital program delivers exercise instructions, progression schedules, and patient education through an app compatible with Android and iOS. Outcomes will include measures of shoulder function, pain, and adherence over the postoperative follow-up period, with in-person visits at the sponsoring center for baseline and follow-up assessments. Participation requires ability to attend Samsung Medical Center in Seoul for enrollment and follow-up and ownership of a smartphone.
Who should consider this trial
Good fit: Adults aged 19 or older who have had rotator cuff repair (with or without concurrent procedures), can use an Android or iOS smartphone, and can attend enrollment and follow-up at Samsung Medical Center are ideal candidates.
Not a fit: Patients expecting revision surgery on the same shoulder, planning contralateral shoulder surgery within a year, lacking a compatible smartphone, or requiring direct manual or invasive therapies are unlikely to benefit from the digital program.
Why it matters
Potential benefit: If successful, this approach could improve recovery and adherence by giving patients structured, at-home rehabilitation guidance and reducing reliance on in-person therapy.
How similar studies have performed: Similar app-based and tele-rehabilitation programs for orthopedic and shoulder recovery have shown improved adherence and functional gains in some studies, but high-quality evidence specifically for rotator cuff repair remains limited and still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be an adult aged 19 or older. 2. Have a diagnosis corresponding to Korean Standard Classification of Diseases codes M75.1 (rotator cuff tear) or S46.08 (other specified injuries of tendons and muscles at shoulder and upper arm), and have undergone rotator cuff repair (RCR) surgery, or RCR combined with procedures such as acromioplasty, biceps tenotomy, fixation, or labrum repair. 3. Own a smartphone operating on the Android or iOS platform. 4. Have received a full explanation of this clinical trial, understood it, voluntarily agreed to participate, and provided written consent to comply with study precautions. Exclusion Criteria: 1. History of previous rotator cuff repair surgery on the same site (revision surgery). 2. Planning or recommendation by medical staff for contralateral rotator cuff repair surgery within one year after enrollment. 3. Plans to receive direct manual therapy or invasive procedures (e.g., oriental medicine treatments, injections, regenerative therapies) at the surgical site through inpatient or outpatient care at another hospital within one year post-discharge. 4. Presence of severe underlying conditions, neuromusculoskeletal disorders, visual impairment, uncontrolled diabetes, cardiovascular disorders, or other comorbidities that hinder participation in rehabilitation exercises. 5. Difficulty using clinical trial medical devices due to cognitive impairment (e.g., dementia), visual impairment, or digital illiteracy. 6. Other cases where the medical staff judges that unsupervised rehabilitation exercise is contraindicated or the principal investigator deems the subject unsuitable for the clinical trial.
Where this trial is running
Seoul, Republic of Korea
- Samsung medical center — Seoul, Republic of Korea, South Korea (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear, Rotator Cuff Tear Arthropathy, repair of a cuff tear, digital therapeutics, rehabilitarion